Page 1 of 2

Certificate of Analysis

Renata Limited Print Date: 19-Oct-2022

Nayapara, Bhawal Mirzapur, Rajendrapur, Gazipur-1700
1700 GAZIPUR
BANGLADESH

____________________________________________________________________________

Product Name: Endotoxin, E. coli O55:B5

Vial for Pyrogent - 5000
Material Number: 7460
Batch No: 0001077861
Manufacturing Date: 07-Jan-2022
Expiration Date: 07-Jan-2026

____________________________________________________________________________

SPECIFICATION
Test RESULT MIN MAX UNIT
____________________________________________________________________________
Appearance:
Lyophilized Pass PASS ***
Reconstituted Pass PASS ***
Sterility:
Bulk Negative NEGATIVE ***
Final Container Negative NEGATIVE ***
Residual Moisture (%) 0.4 *** <5.0

Additional Information:
Refer to matched lysate Certificate of Analysis for endotoxin reconstitution volume.

Store lyophilized endotoxin at 2-8 degrees C. Reconstituted endotoxin is stable up to four weeks at 2-8 degrees C.

Christine Leatherman
Electronically signed by Christine Leatherman
Date: 31-JAN-2022 06:55:39 EST
Release ( Inspection Lot: Usage Decision )

This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's
Quality System. This document was generated from a validated Part 11-compliant electronic system Lonza Walkersville Inc.
and thus handwritten signatures are not required. 8830 Biggs Ford Road
Walkersville, MD 21793 8415
For Technical Assistance, call 1-800-521-0390 Tel (301) 898 7025
Fax (301) 845 4024
 Page 2 of 2

Certificate of Analysis

Renata Limited Print Date: 19-Oct-2022

Nayapara, Bhawal Mirzapur, Rajendrapur, Gazipur-1700
1700 GAZIPUR
BANGLADESH

____________________________________________________________________________

Product Name: Endotoxin, E. coli O55:B5

Vial for Pyrogent - 5000
Material Number: 7460
Batch No: 0001077861
Manufacturing Date: 07-Jan-2022
Expiration Date: 07-Jan-2026

____________________________________________________________________________

SPECIFICATION
Test RESULT MIN MAX UNIT
____________________________________________________________________________

This lot has been reviewed by Quality Assurance in compliance with requirements of Lonza's
Quality System. This document was generated from a validated Part 11-compliant electronic system Lonza Walkersville Inc.
and thus handwritten signatures are not required. 8830 Biggs Ford Road
Walkersville, MD 21793 8415
For Technical Assistance, call 1-800-521-0390 Tel (301) 898 7025
Fax (301) 845 4024